BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 23459691 · Received November 3, 2025

    Report

    Report Number
    1213809-2025-00697
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 5, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)- SUPPLEMENTAL MDR - FOREIGN MATTER TWO SAMPLES AND TWO PHOTOS OF 10 ML LUER-LOK SYRINGES (PART NUMBER 309605) WERE RECEIVED AND EVALUATED. ONE SYRINGE SHOWED SIGNIFICANT DAMAGE TO THE PLUNGER ROD, WHILE THE OTHER HAD A GREY, GREASE-LIKE RESIDUE ON THE BARREL, PLUNGER ROD, AND STOPPER IN THE NON-FLUID PATH, CONSISTENT WITH MANUFACTURING GREASE. ADDITIONALLY, THE PHOTOS INDICATED THAT BOTH SYRINGES CONTAINED AN UNKNOWN CLEAR FLUID¿ONE SHOWING PLUNGER DAMAGE AND THE OTHER SHOWING FOREIGN MATTER. THESE CONDITIONS ARE NON-CONFORMING TO PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER IN THE NON-FLUID PATH IS LINKED TO THE MOLDING PROCESS, WHILE THE POTENTIAL ROOT CAUSE FOR THE PLUNGER ROD DAMAGE IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBERS 4354977 AND 5211788. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309605, LOT#: UNKNOWN (POTENTIAL LOT: 4354977, 5211788). RCC RECEIVED A COMPLAINT VIA EMAIL. DURING COMPOUNDING OF LOT#: 20251014-89A41D THE FOLLOWING SYRINGE ISSUES WERE NOTICED. 1 DEFORMED PLUNGER AND BARREL - AVAILABLE FOR RETURN. 1 DEFORMED BARREL - AVAILABLE FOR RETURN. TWO LOT# WERE USED IN COMPOUNDING SO I¿M UNSURE WHICH LOT# BELONGS TO THE COMPLAINT UNITS. DATE WAS ON (B)(6) 2025. NO PATIENT INVOLVEMENT. ON (B)(6) 2025. PCC-25-137. STERILE SYRINGE TRAY 10ML. 309605 EXPIRY 6/30/2030 AND 11/30/2029. DEFORMED SYRINGE. PLUNGER AND BARREL DEFORMED, BLACK INK ON INSIDE OF BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701789 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown